Prostate Cancer Clinical Trial
— UnicornOfficial title:
Magnetic Resonance Imaging-guided Focal Laser Ablation of Prostate Cancer
Magnetic resonance imaging-guided focal laser ablation of prostate cancer.
Status | Recruiting |
Enrollment | 53 |
Est. completion date | July 1, 2024 |
Est. primary completion date | July 1, 2022 |
Accepts healthy volunteers | No |
Gender | Male |
Age group | 45 Years to 76 Years |
Eligibility | Inclusion criteria: - MRI visible index lesion (on T2-weighted MR imaging or diffusion weighted imaging); - Maximum MRI visible lesion size is = 15 mm large axis; - Life expectancy at inclusion of more 10 years; - Diagnosis of prostate cancer confirmed by targeted biopsy using TRUS-MRI fusion or in-bore MRI guided biopsies; - Criteria of low and intermediate risk of progression and eligibility for focal therapy (clinical stage of maximum T2c, maximum biopsy Gleason score of 4 + 3 on targeted biopsies, serum prostate specific antigen < 15 ng/ml); - Patient accepting to be included in an active surveillance protocol at the end of the study, in accordance with the recommendations of good practice. Exclusion criteria: - History of prostate surgery; - History of radiation therapy or pelvic trauma; history of proved acute or chronic prostatitis; - History of tumor in the preceding 5 years (excluded: non-metastatic basal cell skin cancer); - Severe urinary symptoms associated with benign hyperplasia of the prostate, and defined by an IPSS score > 18; - Tumor with MRI signs of extra-capsular extension or invasion of the seminal vesicles; - Maximum cancer core length >3 mm and/or maximum Gleason score of 3+4 on systematic biopsies outside the visible tumor area on mpMRI; - Impossibility to obtain a valid informed consent; - Patients unable to undergo MR imaging, including those with contra-indications; - Contra-indications to MR guided focal laser therapy (colitis ulcerosa, rectal pathology or abdomino perineal resection); - Metallic hip implant or any other metallic implant or device that distorts local magnetic field and compromises the quality of MR imaging; - Patients with evidence for nodal or metastatic disease; - Patients with an estimated Glomerular Filtration Ratio (eGFR) < 40 mL/min/1.73 m2. |
Country | Name | City | State |
---|---|---|---|
Netherlands | Radboudumc | Nijmegen |
Lead Sponsor | Collaborator |
---|---|
Radboud University | Biolitec, Siemens Corporation, Corporate Technology, Soteria Medical |
Netherlands,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Urine incontinence incontinence | To evaluate a change in the functional outcome urine incontinence before and after FLA in patients with localized low to intermediate risk prostate cancer (Gleason 3+3, 3+4 or Gleason 4+3). | At inclusion, 3 months, 6 months, 12 months and 24 months follow up. | |
Secondary | Local cancer control | To assess the safety outcome local cancer control achieved at the ablation site after FLA by multiparametric MR imaging and targeted prostate biopsies. | At inclusion , 3 months, 6 months, 12 months and 24 months follow up. | |
Secondary | International Prostate Symptom Score (IPSS) | To evaluate other functional outcomes (sexual, hormonal and bowel functions) before and after FLA in men with prostate cancer by using validated questionnaires e.g. International Prostate Symptom Score (IPSS) | At inclusion, 3 months, 6 months, 12 months and 24 months follow up. | |
Secondary | Sexual Health Inventory for Men- International Index of Erectile Function (SHIM-IIEF) | To evaluate other functional outcomes (sexual, hormonal and bowel functions) before and after FLA in men with prostate cancer by using validated questionnaires e.g. Sexual Health Inventory for Men- International Index of Erectile Function (SHIM-IIEF) | At inclusion, 3 months, 6 months, 12 months and 24 months follow up. | |
Secondary | International Consultation on Incontinence Questionnaire (ICIQ) | To evaluate other functional outcomes (sexual, hormonal and bowel functions) before and after FLA in men with prostate cancer by using validated questionnaires e.g. the International Consultation on Incontinence Questionnaire (ICIQ). | At inclusion, 3 months, 6 months, 12 months and 24 months follow up. | |
Secondary | Quality of life using a validated quality of life questionnaire (EORTC QLQ PR25 | To evaluate quality of life before and after FLA in men with prostate cancer by using a validated quality of life questionnaire (EORTC QLQ PR25). | At inclusion , 3 months, 6 months, 12 months and 24 months follow up. | |
Secondary | Complication rate | To evaluate the complication rate related to the technique | At inclusion , 3 months, 6 months, 12 months and 24 months follow up. |
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